24 February 2020 - Today, the FDA is releasing the first phase of the enhancement of the “Purple Book: Database of ...
14 February 2020 - Biosimilars have the potential to broaden patient access to biologics and provide cost savings for health care ...
5 February 2020 - This guidance provides recommendations to applicants seeking licensure under section 351(k) of the Public Health Service Act ...
3 February 2020 - The U.S. Food and Drug Administration and the Federal Trade Commission today signed a joint statement regarding ...
20 January 2020 - In a recent column in Evidence-Based Oncology, Kathy Oubre, MS, chief operating officer of Pontchartrain Cancer ...
19 December 2019 - Filing for ABP 798 supported by two comparative clinical studies. ...
17 December 2019 - Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is ...
11 December 2019 - An agreement on the United States–Mexico–Canada Agreement, a trade deal that updates the North American Free ...
6 December 2019 - Amgen's fourth FDA approval from biosimilars portfolio. ...
25 November 2019 - Access to affordable insulin can be a matter of life and death for Americans with diabetes. ...
19 November 2019 - Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license ...
18 November 2019 - Pfizer today announced the United States FDA has approved Abrilada (adalimumab-afzb), as a biosimilar to Humira ...
15 November 2019 - Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. ...
7 November 2019 - Truxima available week of November 11. ...
4 November 2019 - As the number of biosimilar approvals continues to rise in the US, the number of biosimilar ...